E4301 Basic Surgical Pack SMS E4301

GUDID 00816953020831

EXACT MEDICAL MANUFACTURING, INC.

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use
Primary Device ID00816953020831
NIH Device Record Key99a9bcdc-947b-41a3-8224-339c313fd1b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameE4301 Basic Surgical Pack SMS
Version Model NumberE4301
Catalog NumberE4301
Company DUNS014464314
Company NameEXACT MEDICAL MANUFACTURING, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com
Phone716-681-0866
Emailrdean@exactmm.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816953020824 [Primary]
GS100816953020831 [Package]
Contains: 00816953020824
Package: Case [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2016-10-07

Devices Manufactured by EXACT MEDICAL MANUFACTURING, INC.

26975424195237 - Exact Medical Manufacturing2024-04-04 Hemorrhage View C-Section Drape, Sterile, Pear Shaped fenestration within incision panel
26975424195251 - Exact Medical Manufacturing2024-04-04 Hemorrhage View C-Section Drape,Sterile, full incision panel
16975424195285 - Exact Medical Manufacturing2024-04-04 Foot Switch Cover with drawstring 36x76cm - 14"x30"
16975085705526 - Exact Medical2024-03-27 Foot Switch Cover, Drawstring and adjuster 56x51cm - 22"x20"
16975424194653 - 3M2023-12-26 Instrument Table Cover 100cmx150cm (76cmx150cm reinf) UDI-DI - 159309803EQCJL
16975424194660 - 3M2023-12-26 Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI-159309803EQCJL
16975424194677 - 3M2023-12-26 Instrument Table Cover 200cmx228cm (90cmx228cm reinf) UDI-DI - 159309803EQCJL
16975424194684 - 3M2023-12-26 Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI - 159309803EQCJL
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